Sleepiz One+ Versus Capnography and Electrocardiography (SPZCAP)

May 4, 2023 updated by: Sleepiz AG

Single-center Evaluation of Sleepiz One+ in Measuring Respiration Rate and Heart Rate Compared to Gold Standard

EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the patient's mouth or nose and a monitor that displays the concentration of carbon dioxide in the respiratory gases in real-time.

EtCO2 capnography is generally considered a reliable and accurate method for monitoring respiration and is often used as a gold standard for comparing the performance of other methods for measuring respiration.

Therefore, the primary aim of this study is to provide a thorough comparison of the performance of Sleepiz One+ and EtCO2 Capnography for measuring respiration rate, in healthy adults and patients suffering from chronic conditions (e.g. hypertension, COPD, asthma, diabetes), at rest in a clinical setting. Additionally, the performance of heart rate estimation will be evaluated against ECG.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Zurich
      • Zürich, Zurich, Switzerland, 8044
        • Schlaflabor Fluntern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patients:

  • Age >=18years
  • Informed Consent as documented by signature
  • One (or more) chronic medical condition/s (e.g., diabetes, asthma, cardiovascular or respiratory diseases, etc.)

Healthy volunteers

  • Age >=18years
  • Informed Consent as documented by signature
  • No diagnosed chronic medical condition

Exclusion Criteria:

Patients

  • Previous enrolment into the current study,
  • Cardiac pacemaker or another implanted electrical device
  • Women who are pregnant or breastfeeding
  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant

Healthy volunteers:

  • Previous enrolment into the current study,
  • Cardiac pacemaker or another implanted electrical device
  • Women who are pregnant or breastfeeding
  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, delirium etc. of the participant
  • Presence of diagnosed chronic medical condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sleepiz One+ vs. gold standard
Each enrolled participant will undergo a simultaneous recording with the Sleepiz One+, Capnography device and cardiorespiratory polygraphy with reduced number of channels (ECG and REB only) to measure respiration rate at and heart rate at rest, while sitting and lying down on a bed.
Device: Sleepiz One+
In this study Sleepiz One+ will measure heart rate and respiration rate of a participant sitting or lying in different positions (right and left side, back, abdomen) on a bed. The recording will take around 35 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Respiration rate measurement accuracy per 60s epoch against visually scored capnography data, recorded on subjects lying down and resting on a bed.
Time Frame: 60s
60s

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sleepiz AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2023

Primary Completion (Actual)

April 6, 2023

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

January 25, 2023

First Posted (Actual)

February 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-007-CI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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